[Updated, 12/22/14, 4:02 pm ET] ImmusanT is trying to prove that a vaccine it’s developing can help celiac patients eat gluten without getting sick. Today, the Cambridge, MA-based company got enough dough to test that theory in real patients.
ImmusanT has raised a $12 million Series B round from Vatera Healthcare Partners, the New York backer that helped get the startup off the ground in 2011 with a $20 million equity financing. ImmusanT will use the cash to take Nexvax2, the company’s experimental immunotherapy for celiac disease, through a Phase 2 proof-of-concept study. It’s the first time Nexvax2 will be tested in patients with the disorder—a critical moment in the company’s progression. Those studies are expected to begin in early 2015.
ImmusanT’s vaccine is meant to train the immune systems of celiac disease patients to tolerate gluten—a protein found in wheat, barley, and rye—rather than seeing it as a foreign invader and mounting an attack. Those attacks, which occur when immune cells misidentify fragments of the protein, impair the body’s ability to absorb nutrients. This leads to things like abdominal pain, vomiting, and diarrhea, and potentially much more significant problems like osteoporosis or infertility, if left unchecked.
Celiac disease is a big deal—it affects about 3 million people in the U.S., and the only real option for patients is to completely avoid gluten. And ImmusanT isn’t the only one trying to find new ways to treat it. Baltimore, MD-based Alba Therapeutics, for instance, is one of a few companies developing treatments that are supposed to be taken in combination with a gluten-free diet; it announced positive results from a mid-stage trial in February, along with plans to start designing a late-stage study (Alba hasn’t posted an update about that trial as of yet). Alba’s drug, larazotide, has also gotten a fast-track designation from the FDA, which would speed the agency’s review of the treatment. San Carlos, CA-based Alvine Pharmaceuticals is also pursuing a celiac therapy with the help of AbbVie. And the GlaxoSmithKline/Avalon Ventures collaboration formed Sitari Pharmaceuticals for that purpose in late 2013.
ImmusanT’s approach is different. Based on discoveries immunologist Bob Anderson made more than a decade ago at the University of Oxford, the company intends to inject patients with a vaccine that has engineered version of the three gluten fragments that trigger an immune response in most celiac patients. These peptides are supposed to train the immune system to see gluten as food—much in the way allergy shots help the body gradually learn to tolerate an allergen through periodic injections. The company is also developing a blood-based diagnostic for celiac, and a companion diagnostic to help it identify the patients that might best respond to Nexvax2. I profiled the company’s mission back in March.
So far, ImmusanT has run two Phase 1b trials for Nexvax2—early studies designed to find whether a drug is safe and tolerable, a range of potential doses patients can handle, and whether the therapy appears to be doing what it’s supposed to do on a molecular level. ImmusanT says those studies achieved their objectives—now it’s time to see if that translates to an impact in celiac patients.
[Updated with CEO comments] ImmusanT president and CEO Leslie Williams said in an e-mail that the company is conducting two studies. In the first trial, it’ll assess its companion diagnostic. The second study is a placebo-controlled trial designed to see to assess Nexvax2’s efficacy—as in, whether the therapy can induce tolerance to gluten, and prevent patients from relapsing after the protein is reintroduced into their system. If ImmusanT is successful? Then it can start thinking about using its peptide immunotherapy approach for other diseases too.
“Induction of antigen specific immune tolerance is the holy grail for the treatment of autoimmune disease,” Williams said.
